Regulatory Path Dependence in High-Risk Implantable Medical Devices: Lessons from PIP/M-Implants, BellaGel, and Bouns (Preprint)

UNSTRUCTURED Regulatory history does not necessarily disappear following commercial rebranding, particularly for high-risk implantable medical devices. This article introduces the concept of regulatory path dependence, whereby historical regulatory events continue to influence future regulatory review, market acceptance, and international commercialization despite changes in product names or marketing strategies. Using the sequential evolution from PIP/M-Implants to BellaGel and subsequently Bouns, this review examines how regulatory continuity may persist across apparently distinct commercial products. Particular attention is given to the continued use of the identical Korean Ministry of Food and Drug Safety (KMFDS) approval number (Approval No. 15-1620) for BellaGel and Bouns, illustrating that commercial rebranding may not necessarily constitute regulatory independence. The article further discusses the implications of regulatory path dependence for global market entry, lifecycle regulatory governance, manufacturer credibility, and long-term regulatory trust. We propose that regulatory history should be regarded as a strategic asset that cannot simply be reset through commercial rebranding. This conceptual framework may be applicable not only to breast implants but also to other high-risk implantable medical devices requiring continuous regulatory oversight throughout their lifecycle.